Changing the defaults in organ donation: Moving the goalposts or pitch invasion?

Following a wide consultation and debate, the Organ Donation (Deemed Consent) Bill was recently approved by parliament and will come into effect next year. The new legislation resembles the deemed consent regime introduced in Wales in 2013, and a similar scheme is under consideration in Scotland. Currently, people in England who want to donate their organs have to sign up to the organ donor register; if they do not do so, and they die in a way that makes donation possible, their families will be approached for consent. Families refuse to give this consent around 50% of the time, and even in cases where patients were registered donors, families prevent donation in around 10% of cases; in the year to 2018 this ‘overrule’ rate was 8%. Under the new system, registering as a donor will no longer be required; if there is no evidence that a patient did not want to donate, consent will be ‘deemed’, or presumed. It will still be possible to register as a donor, and everyone should be encouraged to do so, for some of the reasons set out below. This is a fundamental change to the default for consent to organ donation, but there are also other defaults involved, some of which will change and some of which will not.

The new legislation is also known as “Max and Keira’s Law” after two children who were the recipient and donor of a heart in one case. Ironically, the new law will not change the donation default for children, as parents will have to consent to donation. And in fact, the same is effectively true of adults’ organs, because families will still be able to stop donation going ahead (see below); this default will also not change.

Supporters of the new legislation hope that it will increase donation consent rates, and newspaper headlines claimed that it will save “hundreds of lives”. Some countries that have introduced similar ‘presumed consent’ systems have seen donation rates rise, but this is often due to a number of factors including substantial investment, public communication, and societal support. Although initial numbers from Wales are promising, it is still unclear whether the change will bring about the desired results in the context of a resource-constrained NHS in the time of Brexit.

Even if moving to deemed consent will increase the supply of organs, is it ethical to ‘presume’ consent in this way? Many members of the public reacted to the news with the views typically heard when presumed consent is discussed, with variants of “the state has no right to my organs”, “I support donation but will opt out if this is introduced” and “it’s a nanny state.” These “pitch invasion” responses indicate a lack of engagement with what is actually being proposed. The default setting of the consent system is changing, but it still enables citizens to choose. Instead of those who wish to donate having to register as organ donors, those who do not want to donate will have to register their refusal to donate. So these concerns seem overstated, even if it is true that the phrase “deemed consent” does tend to give the impression of “we’re deeming this to be consent even though it isn’t”. More generally, given that upwards of 80% of the population support organ donation but less than half that are registered as donors, changing the default seems to be in line with the public’s preferences regarding donation.

But coverage of deemed consent often overlooks the fact that this change will not solve the family overrule problem. In fact, there is some evidence to suggest that it may make things worse, at least in the short term; in Wales for 2017-2018, families overruled deemed consent in 16 of 49 cases, or 33%. This compares favourably with the 1 in 2 refusal rate for patients who are not registered donors under opt-in in England, but is a lot higher than the 8% overrule rate recorded for registered donors for the same year. Why is this? The reasons that overrule rates in Scotland and England are low is that families are reluctant to go against the recorded wishes of their relative; the donor register provides strong evidence of a wish to donate. By switching the default, the need to register is removed, but so potentially is the strong evidence of consent that the register provides.

We can also think of this in terms of the default for the family. The deemed consent system aims to increase the family consent rate for patients who currently do not register as donors: the default will switch from “do you want to consent to donation from your relative” to “the presumption is that your relative wanted to donate and he didn’t register a refusal”. But for many families of people who would otherwise have registered to donate, the default will switch from “here is evidence that your loved one wanted to donate” to “the presumption is that your relative wanted to donate and he didn’t register a refusal”.” Some families will find this much less persuasive than an entry on the organ donor register.

Note also that these two new defaults are identical. This means that the two current distinct categories of patients with no evidence of consent and patients who would otherwise have registered as donors will be collapsed into one new category of deemed consent. This could result in higher donation rates from the no-consent old category but lower rates in the recorded consent old category. I will explore these ideas further in an article I’m writing for the Journal of Medical Ethics.

Deemed consent may be a good idea in principle, but the evidence is not yet available to say whether it is the right thing to do in practice. Changing the default to deemed consent may reflect general support for organ donation, and people can still refuse to donate, but this change may also make families’ default position become opposition to organ donation, at least in the short term. This would be an unfortunate own goal. In the long term, moving to deemed consent may increase support for donation among families and in society more widely by making organ donation the default for everyone.

Author: David Shaw

Affiliations: Institute for Biomedical Ethics, University of Basel, Switzerland; Department of Health, Ethics and Society, CAPHRI Research Institute, Maastricht University, the Netherlands